FDA Places Idenix Pharma's IDX19368 On Clinical Hold

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8/27/2012 11:24 AM ET

Idenix Pharmaceuticals Inc. (IDIX: Quote) announced that it received verbal notice from the U.S. Food and Drug Administration or FDA that a clinical hold has been placed on IDX19368, the Company's next-generation nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus or HCV infection.

Idenix said that the news follows an announcement that it made on August 16, 2012 related to a partial clinical hold placed on IDX184, the company's lead nucleotide polymerase inhibitor also under development for the treatment of HCV.

The FDA verbally informed Idenix that it placed IDX19368 on clinical hold due to concerns related to the serious cardiac-related adverse events reported for HCV patients treated with BMS-986094, a nucleotide polymerase inhibitor previously under development by Bristol-Myers Squibb Company. To date, no patients have been exposed to IDX19368.

As part of the partial clinical hold placed on IDX184, the FDA has requested additional cardiac testing of patients in the ongoing phase IIb clinical trial of IDX184. More than 50 patients have been scheduled for echocardiograms, and the Company is on track to submit these data to the FDA in the coming weeks.

To date, echocardiograms have been performed on a small number of these patients, and the results are normal.

Idenix said that its primary concern is patient safety and it will work diligently to expedite this review process and continue its discussions with the FDA with the goal of further advancing its drug candidates, IDX184 and IDX19368, in clinical development.

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by RTT Staff Writer

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